Spinal implant system and method

ABSTRACT

A spinal construct includes an existing spinal rod implant defining a rod dimension and having at least one mating surface. At least one extension includes a mating surface engageable with the at least one mating surface of the existing spinal rod implant to comprise a connection haying a dimension the same as the rod dimension. A coupling member is configured to fix the existing spinal rod implant with the at least one extension. Systems, surgical instruments, implants and methods are disclosed.

CROSS REFERENCE TO RELATED APPLICATION

This application claims the benefit of the filing date of U.S.Provisional Application No. 62/256,280, filed on Nov. 17, 2015, thecontents of which being hereby incorporated by reference herein in itsentirety.

TECHNICAL HELD

The present disclosure generally relates to medical devices for thetreatment of musculoskeletal disorders, and more particularly to aspinal implant system and a method for treating a spine.

BACKGROUND

Spinal pathologies and disorders such as scoliosis and other curvatureabnormalities, kyphosis, degenerative disc disease, disc herniation,osteoporosis, spondylolisthesis, stenosis, tumor and fracture may resultfrom factors including trauma, disease and degenerative conditionscaused by injury and aging. Spinal disorders typically result insymptoms including deformity, pain, nerve damage, and partial orcomplete loss of mobility.

Non-surgical treatments, such as medication, rehabilitation and exercisecan be effective, however, may fail to relieve the symptoms associatedwith these disorders. Surgical treatment of these spinal disordersincludes correction, fusion, fixation, discectomy, laminectomy andimplantable prosthetics. As part of these surgical treatments, spinalconstructs including vertebral rods are often used to provide stabilityto a treated region. Rods redirect stresses away from a damaged ordefective region while healing takes place to restore proper alignmentand generally support vertebral members. During surgical treatment, oneor more rods and bone fasteners can be delivered to a surgical site. Therods may be attached via the fasteners to the exterior of two or morevertebral members. This disclosure describes an improvement over theseprior technologies.

SUMMARY

In one embodiment, a spinal construct is provided. The spinal constructincludes an existing spinal rod implant defining a rod dimension andhaving at least one mating surface. At least one extension includes amating surface engageable with the at least one mating surface of theexisting spinal rod implant to comprise a connection having a dimensionthe same as the rod dimension. A coupling member is configured to fixthe existing spinal rod implant with the at least one extension. In someembodiments, systems, surgical instruments, implants and methods aredisclosed.

In one embodiment, a preemptive spinal rod system is provided. Thepreemptive spinal rod system includes a rod portion and a rod extensionportion or portions. The rod extension portion includes a connector endthat is configured to mate with an end of the rod portion such that amedial-to-lateral diameter of a connection region between the rodportion and the rod extension portion is the same as a diameter of therod portion. A fastener is configured to secure the rod extensionportion to the rod portion.

BRIEF DESCRIPTION OF THE DRAWINGS

The present disclosure will become more readily apparent from thespecific description accompanied by the following drawings, in which:

FIG. 1A is a perspective view of components of one embodiment of asystem in accordance with the principles of the present disclosure;

FIG. 1B is a perspective view of the components shown in FIG. 1A;

FIG. 2A is a perspective of components of one embodiment of a system inaccordance with the principles of the present disclosure;

FIG. 2B is a side view of the components shown in FIG. 2A;

FIG. 3A is a side view of the components shown in FIG. 2A;

FIG. 3B is a side view of components of one embodiment of a system inaccordance with the principles of the present disclosure;

FIG. 4A is a perspective view of components of one embodiment of asystem in accordance with the principles of the present disclosure;

FIG. 4B is a &de view of the components shown in FIG. 4A;

FIG. 4C is a perspective view of the components shown in FIG. 4B;

FIG. 5A is a side view of components of one embodiment of a system inaccordance with the principles of the present disclosure;

FIG. 5B is a perspective view of the components shown in FIG. 5A;

FIG. 6A is a side view of components of one embodiment of a system inaccordance with the principles of the present disclosure;

FIG. 6B is a side view of components of one embodiment of a system inaccordance with the principles of the present disclosure;

FIG. 7A is a side view of components of one embodiment of a system inaccordance with the principles of the present disclosure;

FIG. 7B is a perspective view of the components shown in FIG. 7A; and

FIG. 8 is a flow diagram of the steps of a method of one embodiment of asystem in accordance with the principles of the present disclosure.

DETAILED DESCRIPTION

The exemplary embodiments of the surgical system and related methods ofuse disclosed are discussed in terms of medical devices for thetreatment of musculoskeletal disorders and more particularly, in termsof a surgical system and method for treatment of a spine disorder. Insome embodiments, the systems and methods of the present disclosure areemployed with a spinal joint fusion, for example, with a cervical,thoracic, lumbar and/or sacral region of a spine.

In some embodiments, the present system comprises a spinal constructthat includes an existing spinal rod implant engageable with at leastone extension to comprise a connection having a dimension uniform with adimension of the existing spinal rod implant. In some embodiments, theconfiguration of the spinal construct avoids adding bulk to the spinalrod, for example, in a revision surgery and can be disposed withexisting fastener implants and/or newly implanted fasteners. In someembodiments, the present system includes a preemptive spinal rod systemhaving a rod portion, a rod extension portion or portions, and afastener or fasteners. In some embodiments, the rod extension portionincludes a connector end that is configured to mate with an end of therod portion such that a medial-to-lateral diameter of a connection pointbetween the rod portion and the rod extension portion is the same as adiameter of the rod portion. In some embodiments, the fastener isconfigured to secure the rod extension portion to the rod portion.

In some embodiments, the present system includes a spinal rod that canaccommodate a single spinal rod extension. In some embodiments, thepresent system is employed with a method of securing the spinal rod to aspinal rod extension. In some embodiments, the present system isemployed with a method of assembling a spinal rod and a spinal rodextension to comprise a preemptive spinal rod system that is used in anindex or initial spine surgery. In some embodiments, the spinal rod issecured to an elongated spinal rod extension. In some embodiments, thepresent system includes a spinal rod that can accommodate two spinal rodextensions. In some embodiments, the spinal rod is secured to two spinalrod extensions and comprise a preemptive spinal rod system. In someembodiments, the present system is employed with a method of securing afirst spinal rod extension to a spinal rod, with the spinal rod and thefirst spinal rod extension secured to pedicle screws. In someembodiments, the method includes the step of securing the second spinalrod extension to the spinal rod, with the spinal rod and the secondspinal rod extension secured to pedicle screws.

In some embodiments, the present system includes spinal instrumentationto stabilize a spine for a spinal fusion. In some embodiments, thespinal instrumentation can include a spinal rod, which is secured to oneor more vertebrae via pedicle screws. In some embodiments, the presentsystem is employed with a method to treat adjacent segmentdeterioration, which can occur above or below an instrumented spinalfusion. In some embodiments, the method can include revision surgeryand/or an overall longer spinal rod.

In some embodiments, the present system includes a spinal rod systemhaving a modular spinal rod with spinal segments that are mounted to oneanother in a way that does not significantly increase the overall bulkof the spinal rod. In some embodiments, the modular spinal rod can beemployed with a revision surgery that occurs after the modular spinalrod is in place and/or implanted with tissue. In some embodiments, oneor more segments of the spinal rod can be replaced by longer segmentsduring the revision surgery, for example, a minimally invasive surgeryor conventional open surgery. In some embodiments, during a revisionsurgery, a first portion and/or a second portion, for example, a topportion and/or a bottom portion of an existing spinal rod implant isremoved from a main part of the rod, and a rod portion, for example, anextension, which is longer than the first and/or second portions, can beattached to the main part of the rod. In some embodiments, the extensionextends the existing spinal rod implant in one or more directions, forexample, up or down, into newly placed and/or implanted pedicle screws.In some embodiments, the extension can pass through one or morepreviously placed pedicle screws and pass through one or more newlyplaced and/or implanted pedicle screws.

In some embodiments, the present surgical system includes a spinalconstruct that can be employed with a method for treating a spine with aplurality of spinal rod portions, which can be used to hold a spineuntil fusion occurs. In some embodiments, the present surgical systemincludes a spinal construct that can be employed with a method fortreating a spine, which includes a pedicle subtraction osteotomy, atransforaminal lumbar interbody fusion (TLIF) and/or long constructs inheavy patients. In some embodiments, the spinal construct includes aspinal rod disposed with a multi-axial (MAS), fixed axis (FAS) or asagittal adjusting (SAS) pedicle screw.

In some embodiments, the spinal construct includes revisioninstrumentation configured to attach to one or more existing spinalconstructs implanted with a body. In some embodiments, the spinalconstruct can be employed in a revision surgery to extend an existingscrew and rod construct. In some embodiments, the spinal construct canbe employed in a revision surgery to connect an existing spinalconstruct and extend the existing spinal construct to span one or morespinal levels.

In some embodiments, the present surgical system includes a spinalconstruct that can be employed in a revision surgery to connect to anexisting rod implanted with a body. In some embodiments, the spinalconstruct and the existing spinal construct comprise an extension. Insome embodiments, the present surgical system includes a spinalconstruct that can be employed in a revision surgery to connect to anexisting bone screw and rod construct through a minimally invasiveapproach.

In some embodiments, one or all of the components of the surgical systemmay be disposable, peel-pack, pre-packed sterile devices. One or all ofthe components of the system may be reusable. The system may beconfigured as a kit with multiple sized and configured components.

In some embodiments, the surgical system of the present disclosure maybe employed to treat spinal disorders such as, for example, degenerativedisc disease, disc herniation, osteoporosis, spondylolisthesis,stenosis, scoliosis and other curvature abnormalities, kyphosis, tumorand fractures. In some embodiments, the surgical system of the presentdisclosure may be employed with other osteal and bone relatedapplications, including those associated with diagnostics andtherapeutics. In some embodiments, the disclosed surgical system may bealternatively employed in a surgical treatment with a patient in a proneor supine position, and/or employ various surgical approaches to thespine, including anterior, posterior, posterior mid-line, directlateral, postero-lateral, and/or antero-lateral approaches, and in otherbody regions. The surgical system of the present disclosure may also bealternatively employed with procedures for treating the lumbar,cervical, thoracic, sacral and pelvic regions of a spinal column. Thesurgical system of the present disclosure may also be used on animals,bone models and other non-living substrates, such as, for example, intraining, testing and demonstration,

The surgical system of the present disclosure may be understood morereadily by reference to the following detailed description of theembodiments taken in connection with the accompanying drawing figures,which form a part of this disclosure. It is to be understood that thisapplication is not limited to the specific devices, methods, conditionsor parameters described and/or shown herein, and that the terminologyused herein is for the purpose of describing particular embodiments byway of example only and is not intended to be limiting. In someembodiments, as used in the specification and including the appendedclaims, the singular forms “a,” “an,” and “the” include the plural, andreference to a particular numerical value includes at least thatparticular value, unless the context dearly dictates otherwise. Rangesmay be expressed herein as from “about” or “approximately” oneparticular value and/or to “about” or “approximately” another particularvalue. When such a range is expressed, another embodiment includes fromthe one particular value and/or to the other particular value.Similarly, when values are expressed as approximations, by use of theantecedent “about,” it will be understood that the particular valueforms another embodiment. It is also understood that all spatialreferences, such as, for example, horizontal, vertical, top, upper,lower, bottom, left and right, are for illustrative purposes only andcan be varied within the scope of the disclosure. For example, thereferences “upper” and “lower” are relative and used only in the contextto the other, and are not necessarily “superior” and “inferior”.

As used in the specification and including the appended claims,“treating” or “treatment” of a disease or condition refers to performinga procedure that may include administering one or more drugs to apatient (human, normal or otherwise or other mammal), employingimplantable devices, and/or employing instruments that treat thedisease, such as, for example, microdiscectomy instruments used toremove portions bulging or herniated discs and/or bone spurs, in aneffort to alleviate signs or symptoms of the disease or condition.Alleviation can occur prior to signs or symptoms of the disease orcondition appearing, as well as after their appearance. Thus, treatingor treatment includes preventing or prevention of disease or undesirablecondition (e.g., preventing the disease from occurring in a patient, whomay be predisposed to the disease but has not yet been diagnosed ashaving it). In addition, treating or treatment does not require completealleviation of signs or symptoms, does not require a cure, andspecifically includes procedures that have only a marginal effect on thepatient. Treatment can include inhibiting the disease, e.g., arrestingits development, or relieving the disease, e.g., causing regression ofthe disease. For example, treatment can include reducing acute orchronic inflammation; alleviating pain and mitigating and inducingre-growth of new ligament, bone and other tissues; as an adjunct insurgery; and/or any repair procedure. In some embodiments, as used inthe specification and including the appended claims, the term “tissue”includes soft tissue, ligaments, tendons, cartilage and/or bone unlessspecifically referred to otherwise.

The following discussion includes a description of a surgical systemincluding a spinal construct, related components and methods ofemploying the surgical system in accordance with the principles of thepresent disclosure. Alternate embodiments are disclosed. Reference ismade to the exemplary embodiments of the present disclosure, which areillustrated in the accompanying figures. Turning to FIGS. 1A and 1B,there are illustrated components of a surgical system, such as, forexample, a spinal implant system 10.

The components of spinal implant system 10 can be fabricated frombiologically acceptable materials suitable for medical applications,including metals, synthetic polymers, ceramics and bone material and/ortheir composites. For example, the components of spinal implant system10, individually or collectively, can be fabricated from materials suchas stainless steel alloys, aluminum, commercially pure titanium,titanium alloys, Grade 5 titanium, super-elastic titanium alloys,cobalt-chrome alloys, superelastic metallic alloys (e.g., Nitinol, superelasto-plastic metals, such as GUM METAL®), ceramics and compositesthereof such as calcium phosphate (e.g., SKELITE™), thermoplastics suchas polyaryletherketone (PAEK) including polyetheretherketone (PEEK),polyetherketoneketone (PEKK) and polyetherketone (PEK), carbon-PEEKcomposites, PEEK-BaSO₄ polymeric rubbers, polyethylene terephthalate(PET), fabric, silicone, polyurethane. silicone-polyurethane copolymers,polymeric rubbers, polyolefin rubbers, hydrogels, semi-rigid and rigidmaterials, elastomers, rubbers, thermoplastic elastomers, thermosetelastomers, elastomeric composites, rigid polymers includingpolyphenylene, polyamide, polyimide, polyetherimide, polyethylene,epoxy, bone material including autograft. allograft, xenograft ortransgenic cortical and/or corticocancellous bone, and tissue growth ordifferentiation factors, partially resorbable materials, such as, forexample, composites of metals and calcium-based ceramics, composites ofPEEK and calcium based ceramics, composites of PEEK with resorbablepolymers, totally resorbable materials, such as, for example, calciumbased ceramics such as calcium phosphate, tri-calcium phosphate (TCP),hydroxyapatite (HA)-TCP, calcium sulfate, or other resorbable polymerssuch as polyaetide, polyglycolide, polytyrosine carbonate,polycaroplaetohe and their combinations.

Various components of spinal implant system 10 may have materialcomposites, including the above materials, to achieve various desiredcharacteristics such as strength, rigidity, elasticity. compliance,biomechanical performance, durability and radiolucency or imagingpreference. The components of spinal implant system 10, individually orcollectively, may also be fabricated from a heterogeneous material suchas a combination of two or more of the above-described materials. Thecomponents of spinal implant system 10 may be monolithically formed,integrally connected or include fastening elements and/or instruments,as described herein.

Spinal implant system 10 is employed, for example, with a minimallyinvasive procedure, including percutaneous techniques, mini-open andopen surgical techniques to deliver and introduce instrumentation and/orcomponents of spinal constructs at a surgical site within a body of apatient, for example, a section of a spine. In some embodiments, one ormore of the components of spinal implant system 10 are configured forengagement with existing constructs, which may include fastener implantsand/or spinal rod implants attached with vertebrae, in a revisionsurgery to manipulate tissue and/or correct a spinal disorder, asdescribed herein. In some embodiments, one or more of the components ofspinal implant system 10 can be employed in a revision surgery toconnect an existing spinal construct and extend, revise or repair theexisting spinal construct to span one or more spinal levels. Spinalimplant system 10 comprises a spinal construct 12. In some embodiments,one or more components of spinal construct 12 are configured to extendan existing spinal rod implant with or without removing portions of theexisting rod implant. In some embodiments, existing spinal constructsmay include one or more implants of spinal implant system 10 connectedor fixed with tissue in a prior or different surgical procedure,separate in time and/or over a duration of time in the same surgicalprocedure.

Spinal construct 12 includes a spinal rod 100 that can accommodate asingle spinal rod extension. Spinal rod 100 is connectable with a spinalrod extension 150. Spinal rod 100 and spinal rod extension 150 can bestraight as shown, or can be curved to accommodate a patient's anatomy.Spinal rod 100 includes a shaft portion that defines a rod diameterdimension d1 and an end 105. Spinal rod extension 150 includes a shaftportion that defines a rod diameter dimension d2 and an end 155. End 155defines an opening 160 that is configured to receive end 105 of spinalrod 100.

Opening 160 is configured such that a male/female connection 151 betweenspinal rod 100 and spinal rod extension 150 has the same dimension, suchas, for example, a medial-to-lateral thickness, diameter or width ml asrod diameter dimension d1 of spinal rod 100 and/or rod diameterdimension d2 of spinal rod extension 150, as shown in FIGS, 2A and 2B.End 105 includes a male mating part and end 155 includes a female matingpart. Connection 151 can freely fit within and/or pass through aU-shaped head of a pedicle screw, as described herein. In someembodiments, connection 151 can pass freely through the pedicle screwhead in a cephalad/caudal manner. In some embodiments, thisconfiguration facilitates placement of the components of spinalconstruct 12, for example, spinal rod 100 and attached spinal rodextension 150, being placed in a percutaneous manner such that the rodportions of a spinal construct pass freely through a pedicle screw headand any pedicle screw head extensions.

Connection 151 between spinal rod 100 and spinal rod extension 150 issecured by a coupling member, such as, for example, a screw 175. In someembodiments, screw 175 includes a set screw that is configured to passthrough and engage a threaded hole 165 in spinal rod extension 150 andcontact an outer surface of end 105 of spinal rod 100. As set screw 175is tightened, it presses against an outer surface of end 105 and securesspinal rod extension 150 to spinal rod 100. In some embodiments, screw175 extends through a threaded hole in spinal rod extension 150 andthrough a threaded hole in end 105 of spinal rod 100. In someembodiments, two or more screws 175 may be used to secure connection151. In some embodiments, connection 151 may include the ends of spinalrod 100 and spinal rod extension 150 disposed in alternate fixationconfigurations, such as, for example, friction fit, pressure fit,locking protrusion/recess, locking keyway and/or adhesive. In someembodiments, dimensions ml, d1, d2 are equal, substantially the same,the same, constant and/or uniform. In some embodiments, portions ofspinal rod 100 and spinal rod extension 150 may include differentdimensions. In some embodiments, portions of spinal rod 100 and/orspinal rod extension 150 may include different dimensions thanconnection 151. In some embodiments, dimension ml, dimension d1 and/ordimension d2 may include length, width, height, thickness, diameter,circumference, area and/or volume.

In some embodiments, spinal rod extension 150 is secured to spinal rod100 to comprise components of spinal implant system 10 including apreemptive spinal rod system, similar to the systems described herein,which is used in an index or initial spine surgery, as shown in FIGS.2A, 2B and 3A. In use, spinal rod extension 150 includes end 155 withopening 160 (FIGS. 1A and 1B), which receives end 105 of spinal rod 100and is secured by screw 175 to comprise connection 151. Set screw 175 isconfigured to pass through and engage a threaded hole in spinal rodextension 150 and make contact with an outer surface of end 105 ofspinal rod 100. As set screw 175 is tightened, it presses against anouter surface of end 105 and secures spinal rod extension 150 to spinalrod 100. Spinal rod extension 150 is connected, attached, provisionallyfixed, permanently fixed and/or secured to spinal rod 100.

As shown in FIG. 2B, spinal rod extension 150 is secured to spinal rod100 showing that medial-to-lateral dimension ml of spinal rod extensionend 155 and its attachment site to spinal rod end 105 is the same as roddiameter dimension d2 of spinal rod extension 150 and rod diameterdimension d1 of spinal rod 100. This configuration enables connection151 to fit within a U-shaped head of a pedicle screw, such that it canpass freely through the pedicle screw head in a cephalad/caudal manner.Medial-to-lateral dimension ml is consistent and/or uniform throughoutthe rod-to-rod connection. In some embodiments, connection 151 isconfigured to fit within a rigid U-shaped head of a pedicle screw. Insome embodiments, connection 151 comprises a connection region that isthe same width as rod diameter dimensions d1, d2. In some embodiments,connection 151 is larger end/or taller in a sagittal plane of a bodythan rod diameter dimensions d1, d2 to have a connection of sufficientstrength to withstand expected loads. In some embodiments, toaccommodate a variety of biomechanical stresses at connection 151 and/orbetween spinal rod 100 and spinal rod extension 150, spinal rodextension end 155 and spinal rod end 105 may be configured with widermedial-to-lateral diameters, which may strengthen connection 151. Insome embodiments, connection 151 may be configured with widermedial-to-lateral diameters and prevented from passing through selectedpedicle screw heads.

In one embodiment, as shown in FIG. 3B, a spinal construct, similar tospinal construct 12 described herein, includes an elongated spinal rodextension 350 that is secured to spinal rod 100 to comprise componentsof a spinal rod system, similar to the systems described herein. Spinalrod extension 350, similar to extension 150 described herein, includesan end 155 with an opening 160. A connection, similar to connection 151described herein, between spinal rod 100 and spinal rod extension 350 issecured by screw 175, described herein, which passes through and engagesa threaded portion of end 155 and presses tightly against an outersurface of end 105 of spinal rod 100. As such, the spinal construct caninclude a spinal rod extension configured in a variety of lengths. Insome embodiments, spinal rod 100 can be configured in a variety oflengths. In some embodiments, spinal rod 100 and/or spinal rod extension150, 350 can be configured with various bends to accommodate a patient'sanatomy.

In one embodiment, as shown in FIGS, 4A, 4B and 4C, a spinal construct,similar to spinal construct 12 described herein, includes a double-endedspinal rod 400 that is configured with two ends 105. Each end 105 can beattached to a spinal rod extension 150. One spinal rod extension 150 isdisposed at each end of spinal rod 400, similar to that describedherein. Spinal rod extension 150 includes an end 155 with an opening 160that is configured to receive an end 105 of spinal rod 400. Connections,similar to connection 151 described herein, between spinal rod 400 andspinal rod extensions 150 are secured by screws 175, similar to thatdescribed herein.

In some embodiments, two spinal rod extensions 150 are attached to eachend of spinal rod 400 to comprise components of a preemptive spinal rodsystem, similar to the systems described herein, which is used in anindex or initial spine surgery, as shown in FIGS. 4B and 4C. Forexample, the spinal construct, as shown in FIGS. 4B and 4C, can beemployed with a clinical use for a preemptive spinal rod system, asdescribed herein. In some embodiments, the spinal construct, asdescribed herein, may be employed with a method for treating a spinethat includes shortening the spinal construct in a second or revisionsurgery. For example, the spinal construct is implanted in an indexsurgery that involves fusing across one or two intervertebral levels. Insome cases, for example, due to biomechanical concerns of instrumentingonly the fused levels, the spinal construct is extended beyond the fusedlevels into unfused spinal segments. The spinal construct is implantedwith tissue during the index surgery such that during revision surgeryafter the fusion has healed, the rod extension(s), as described herein,which extend into unfused spinal segments can be removed, leaving inplace the spinal rod, as described herein, which spans only the fusedsegments. In some embodiments, this configuration of the preemptivespinal rod system allows for shortening of the spinal construct withoutdisturbing the spinal rod and screws that span the fused segment. Insome embodiments, a spinal construct, similar to those described herein,may be employed with a method for treating a spine that includeslengthening an instrumentation construct in a revision surgery.

In one embodiment, as shown in FIGS, 5A and 5B, a spinal construct,similar to spinal construct 12 described herein, may be employed with amethod for treating a spine, similar to that described herein. Thespinal construct includes spinal rod extension 150 secured to spinal rod100, as described with regard to FIGS. 2A, 2B, and 3A. Spinal rodextension 150 and spinal rod 100 are secured to pedicle screws 500 and505. Connection 151 between end 105 of spinal rod 100 and end 155 ofspinal rod extension 150 is secured by screw 175. Pedicle screws 500 and505 are generally of the same design and configured to beinterchangeable. Pedicle screws 500 are secured to spinal rod 100 andpedicle screw 505 is secured to a spinal rod extension 150. Pediclescrews 500 and 505 each comprise a threaded shaft 560 and a screw head550. Set screws 570 pass through and engage a threaded portion ofpedicle screw head 550 and press tightly against an outer surface of aspinal rod, similar to those described herein to secure the spinal rodto the pedicle screws.

Spinal rod extension 150 is attached to spinal rod 100. Spinal rodextension 150 and spinal rod 100 are attached to pedicle screws 500 and505, for example, which would be used in an initial or index surgery. Insome embodiments, each of pedicle screws 500 and 505 are secured to apatient and inserted into sequential vertebra, thus spanning fivevertebral bodies (not shown) and four disk levels (not shown) to befused. Spinal rod 100 is secured to a patient via three pedicle screws500, and rod extension 150 is secured to the patient by a single pediclescrew 505. In some embodiments, one or more additional spinal rodextensions may be used during the initial or index spinal surgery. Insome embodiments, the spinal construct, as shown in FIGS. 5A and 5B, maybe revised in a surgical procedure to extend the existing spinalconstruct across more vertebra. For example, the revision procedure canbe performed by removing the first spinal rod extension 150 andreplacing it with a longer spinal rod extension, as described herein,which attaches to newly placed and/or implanted additional pediclescrews, as described herein, for example, with regard to FIGS. 6A, 6B,7A and 7B.

In one embodiment, as shown in FIGS. 6A, 6B, 7A and 7B, a spinalconstruct, similar to spinal construct 12 described herein, may beemployed with a method for treating a spine, similar to that describedherein. Set screw 570 is removed from pedicle screw 505 and screw 175 isremoved from a first and/or existing spinal rod extension 150 todisengage first spinal rod extension 150 from both spinal rod 100 andpedicle screw 505. First spinal rod extension 150 is removed from thepatient entirely. The existing spinal construct, as shown in FIG. 6A,shows first spinal rod extension 150 having been removed in a revisionsurgery and spinal rod 100 secured to pedicle screws 500. Pedicle screw505 has not been removed from the patient during revision surgery andremains in place to secure a newly placed, elongated spinal rodextension 350, as shown in FIG. 6B. In some embodiments, an insertiontool may be attached to end portion 105 to facilitate percutaneousplacement of second rod extension 350. New pedicle screws 510, similarto pedicle screws 500 and 505, have been implanted in a patient toextend the spinal construct across two more vertebra (not shown).Pedicle screws 500 are secured to spinal rod 100 and pedicle screws 505,510 are secured to second spinal rod extension 350. New pedicle screws510 will accommodate the longer second rod extension 350. In someembodiments, one or more new pedicle screws 510 can be implanted duringa revision surgery, and a second rod extension of variable lengthplaced. In some embodiments, a double-ended spinal rod with spinal rodextensions at both ends, similar to that described with regard to FIGS.4A, 4B and 4C, can be placed during the index surgery. In someembodiments, one or both of the first spinal rod extensions can bereplaced with longer second spinal rod extension(s) that attach to newpedicle screws 510.

Second spinal rod extension 350 is secured to spinal rod 100, and spinalrod 100 and second spinal rod extension 350 are secured to pediclescrews 500, 505, 510, as described herein and shown in FIGS. 7A and 7B.Spinal rod extension 350 is secured to spinal rod 100 to comprisecomponents of a preemptive spinal rod system, similar to the systemsdescribed herein, and used in a revision spine surgery, similar to thesurgical procedures described herein. The connection, similar toconnection 151 described herein, between end 105 of spinal rod 100 andend 155 of second spinal rod extension 350 is secured by screw 175. Setscrews 570 secure spinal rod 100 and attached spinal rod extension 350to pedicle screws 500, 505, 510. Pedicle screws 500, 505 were implantedin the index surgery. During revision surgery, pedicle screw 505 remainsin place and set screw 570 is removed to allow for rod removal, asdescribed herein. Pedicle screws 510 are newly implanted during therevision surgery, and may span one or more additional vertebra (notshown). In some embodiments, two new pedicle screws 510 are implanted intwo new vertebra (not shown) and span two additional disk levels (notshown). In some embodiments, one or more new pedicle screws 510 may beplaced, and a second rod extension 350 of variable length chosen to spanthe newly placed pedicle screws 510.

In assembly, operation and use, a spinal implant system, similar to thesystems and methods described herein, can be employed with a surgicalprocedure, such as, for example, a surgical treatment of an applicablecondition or injury of an affected section of a spinal column andadjacent areas within a body. In some embodiments, the spinal implantsystem includes a spinal construct, similar to those described herein,which can be employed in a surgical treatment such as an index surgeryand/or a revision surgery to revise, repair and/or extend an existingspinal construct. In some embodiments, the spinal implant systemincludes components employed in a revision surgery to connect with anexisting spinal construct and extend the existing spinal construct tospan one or more spinal levels. In some embodiments, the existing spinalconstruct may include one or more implants connected or fixed withtissue in a prior or different surgical procedure, separate in timeand/or over a duration of time in the same surgical procedure. In someembodiments, during a surgical treatment, components of the spinalimplant system may be completely or partially revised, removed orreplaced.

For example, as shown in FIG. 8, the components of a spinal implantsystem, as described herein, can be employed with a method for treatinga spine using a preemptive spinal rod system. In some embodiments,fewer, additional, and/or different operations may be performed, in someembodiments, an operation 800 includes implanting a preemptive spinalrod system during an initial or index surgery on a patient. Thepreemptive spinal rod system includes a spinal rod with one or morespinal rod extensions mounted thereto, as described herein. In someembodiments, the spinal rod can include a spinal rod extension mountedto each end of the spinal rod. In some embodiments, more than one spinalrod extension may be mounted to each end of the spinal rod. In someembodiments, the preemptive spinal rod system can be pre-formed to thepatient's anatomy and/or cut to length in advance of or during surgery.

In some embodiments, during surgery, a surgeon makes an incision duringopen procedures or a series of incisions during minimally invasivepercutaneous procedures such that a number of pedicle screws can besecured to the patient. The preemptive spinal rod system is theninserted through U-shaped heads of pedicle screws. In some embodiments,the pedicle screw extensions are removed in cases when percutaneousscrews are placed. Set screws are inserted into the U-shaped heads tokeep the preemptive spinal rod system within the U-shaped pedicle screwheads, as described herein, and the incision(s) closed. The rods and rodextensions of the preemptive spinal rod system are inserted andpositioned with the patient, as described herein, with surgicalinstruments. In some embodiments, an insertion tool may be detachablymounted to ends of rods and rod extensions of the preemptive spinal rodsystem. In connection with a surgical procedure, to treat a selectedsection of vertebrae, a surgeon obtains access to a surgical siteincluding vertebrae in any appropriate manner, such as through incisionand retraction of tissues. In some embodiments, the spinal implantsystem can be used in any surgical method or technique including opensurgery, mini-open surgery, minimally invasive surgery and percutaneoussurgical implantation, whereby vertebrae is accessed through amini-incision, or a sleeve that provides a protected passageway to thearea. Once access to the surgical site is obtained, the particularsurgical procedure can be performed for treating the spine disorder.

In some cases, a patient who has had an initial or index spinal surgerymay experience issues with spinal segments that are adjacent to thespinal segments secured by an initial implant. In some cases, thepatient needs a revision surgery to correct any issues. In an operation805, during such a revision surgery, the surgeon removes one or more setscrews that maintain an existing spinal rod extension, for example,inserted during the initial surgery as part of the preemptive spinal rodsystem, within the U-shaped heads of pedicle screws. In an operation810, the surgeon removes the existing spinal rod extension from thepatient using an insertion/removal tool or tools, as described herein.Removal of the existing spinal rod extension includes disconnecting theextension from the existing spinal rod of the preemptive spinal rodsystem by removing/loosening the screw(s) or other fastener(s) that areused to secure the connection, as described herein.

In an operation 815, the surgeon inserts one or more new pedicle screwsinto the patient that will be used to secure a new spinal rod extension,as described herein. The new (or replacement) spinal rod extension,which can be of a different length and/or shape than the existing spinalrod extension, is used to correct the issue, which prompted the revisionsurgery. In an operation 820, the surgeon inserts the new spinal rodextension through the newly inserted pedicle screw heads and alsothrough one or more existing pedicle screw heads that are part of thepedicle screw(s) used to secure the removed spinal rod extension fromthe initial surgery. In some embodiments, the existing pedicle screw(s)may be removed or repositioned. The new spinal rod extension can beinserted using an insertion tool, which is detachably secured to an endof the new spinal rod extension.

In an operation 825, the surgeon mounts the new spinal rod extension tothe existing spinal rod that was inserted during the initial surgery, asdescribed herein. The surgeon mounts the new extension to the existingspinal rod using one or more screw(s) or other fastener(s), as describedherein. In an operation 830, the surgeon secures the new spinal rodextension to the patient by inserting set screws into the U-shaped headsof all pedicle screws through which the new spinal rod extension travelsor extends.

In some embodiments, the components of the preemptive spinal rod systemsdescribed herein can include rods, extensions and portions thereofhaving a linear, axial and/or straight configuration that can be placedas-is into a patient. In some embodiments, the components of thepreemptive spinal rod systems described herein can include rods,extensions and portions thereof being flexible and bendable prior toimplantation to match the patient's anatomy. In some embodiments, thecomponents of the preemptive spinal rod systems described herein caninclude rods, extensions and portions thereof having a pre-contouredconfiguration, for example, pre-bent to match a patient's lordotic orkyphotic spine segment.

Upon completion of the procedure, the surgical instruments, assembliesand non-implanted components of the spinal implant system are removedfrom the surgical site and the incision is closed. One or more of thecomponents of the spinal implant system can be made of radiolucentmaterials such as polymers. Radiomarkers may be included foridentification under x-ray, fluoroscopy, CT or other imaging techniques.In some embodiments, the use of surgical navigation, microsurgical andimage guided technologies may be employed to access, view and repairspinal deterioration or damage, with the aid of the spinal implantsystem.

In some embodiments, the spinal implant system includes an agent, whichmay be disposed, packed, coated or layered within, on or about thecomponents and/or surfaces of the spinal implant system. In someembodiments, the agent may include bone growth promoting material, suchas, for example, bone graft to enhance fixation of the bone fastenerswith vertebrae. In some embodiments, the agent may include one or aplurality of therapeutic agents and/or pharmacological agents forrelease, including sustained release, to treat, for example, pain,inflammation and degeneration. In some embodiments, the existingfastener implant or pedicle screw, as described herein, may includesagittal angulation screws, mono-axial screws, uni-planar screws, fixedscrews, anchors, hooks, tissue penetrating screws, conventional screws,expanding screws, wedges, anchors, buttons, clips, snaps, frictionfittings, compressive fittings, expanding rivets, staples, nails,adhesives, posts, connectors, fixation plates and/or posts. In someembodiments, the spinal implant system can include one or a plurality ofspinal constructs, rods and/or extensions, such as those describedherein, which may be employed with a single vertebral level or aplurality of vertebral levels. In some embodiments, the spinal implantsystem can include one or a plurality of spinal constructs, rods and/orextensions, such as those described herein, may be engaged withvertebrae in various orientations, such as, for example, series,parallel, offset, staggered and/or alternate vertebral levels.

It will be understood that various modifications may be made to theembodiments disclosed herein. Therefore, the above description shouldnot be construed as limiting, but merely as exemplification of thevarious embodiments. Those skilled in the art will envision othermodifications within the scope and spirit of the claims appended hereto.

What is claimed is:
 1. A preemptive spinal rod system comprising: a rodportion; a rod extension portion or portions, wherein the rod extensionportion includes a connector end that is configured to mate with an endof the rod portion such that a medial-to-lateral diameter of aconnection region between the rod portion and the rod extension portionis the same as a diameter of the rod portion; and a fastener configuredto secure the rod extension portion to the rod portion.
 2. A spinalconstruct comprising: an existing spinal rod implant defining a roddimension and having at least one mating surface; at least one extensionincluding a mating surface engageable with the at least one matingsurface of the existing spinal rod implant to comprise a connectionhaving a dimension the same as the rod dimension; and a coupling memberconfigured to fix the existing spinal rod implant with the at least oneextension.
 3. A spinal construct as recited in claim 2, wherein theexisting spinal rod implant includes a shaft that defines the roddimension and an end that includes the at least one mating surface.
 4. Aspinal construct as recited in claim 2, wherein the existing spinal rodimplant includes a shaft having a constant rod diameter dimension and anend that includes a male mating part.
 5. A spinal construct as recitedin claim 2, wherein the existing spinal rod implant includes a shaftthat defines the rod dimension, and a first end that includes a firstmating surface and a second end that includes a second mating surface.6. A spinal construct as recited in claim 2, wherein the existing spinalrod implant includes a shaft having a constant rod diameter dimension,and a first end that includes a first male mating part and a second endthat includes a second male mating part.
 7. A spinal construct asrecited in claim 2, further comprising a plurality of extensions.
 8. Aspinal construct as recited in claim 2, wherein the at least oneextension includes a shaft that defines a rod dimension that is the sameas the dimension of the connection.
 9. A spinal construct as recited inclaim 2, wherein the at least one extension includes a shaft thatdefines a rod dimension that is the same as the dimension of theconnection and an end that includes a female mating part.
 10. A spinalconstruct as recited in claim 2, wherein the existing spinal rod implantincludes a first end that includes a first mating surface engageablewith a first rod extension and a second end that includes a secondmating surface engageable with a second rod extension.
 11. A spinalconstruct as recited in claim 2, wherein the existing spinal rod implantincludes a first end that includes a first male mating part engageablewith a female mating part of a first rod extension and a second end thatincludes a second male mating part engageable with a female mating partof a second rod extension.
 12. A spinal construct as recited in claim 2,wherein the dimension of the connection includes a medial-to-lateralwidth.
 13. A spinal construct as recited in claim 2, wherein thecoupling member includes a set screw.
 14. A spinal construct as recitedin claim 2, wherein the coupling member is engageable with the existingspinal rod implant and the at least one extension.
 15. A spinalconstruct as recited in claim 2, wherein the connection is disposablewithin a cavity of a receiver of an existing pedicle screw implant. 16.A spinal implant system comprising: at least one existing fastenerimplant, each of the existing fastener implants defining a cavityconfigured for disposal of an existing spinal rod implant, the existingspinal rod implant defining a rod dimension and having at least onemating surface; a first, removable extension including a mating surfaceengageable with the at least one mating surface of the existing spinalrod implant to comprise a connection having a dimension the same as therod dimension; a coupling member configured to fix the existing spinalrod implant with an extension; and a second extension configured toreplace the first extension, the second extension including a matingsurface engageable with the at least one mating surface of the existingspinal rod implant to comprise a connection having a dimension the sameas the rod dimension.
 17. A spinal implant system as recited in claim16, wherein the existing spinal rod implant includes a shaft having aconstant rod diameter dimension and an end that includes a male matingpart.
 18. A spinal implant system as recited in claim 16, wherein thefirst extension includes a shaft that defines a diameter dimension thesame as the rod dimension and an end that includes a female mating part.19. A spinal implant system as recited in claim 16, wherein the secondextension includes a shaft that defines a diameter dimension the same asthe rod dimension and an end that includes a female mating part.
 20. Aspinal construct as recited in claim 16, wherein the dimension of aconnection includes a medial-to-lateral width.